Trial Outcomes & Findings for An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab (NCT NCT02754141)
NCT ID: NCT02754141
Last Updated: 2023-04-05
Results Overview
Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
235 participants
Primary outcome timeframe
From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.
Results posted on
2023-04-05
Participant Flow
235 participants treated
Participant milestones
| Measure |
P1A 150mg
BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy
|
P1A 300mg
BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy
|
P1A 600mg
BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy
|
P1A 1200mg
BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy
|
P1A 1600mg
BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Monotherapy
BMS-986179 600mg Q2W monotherapy
|
P2 RCC Combo Therapy
BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
12
|
12
|
9
|
12
|
9
|
8
|
7
|
18
|
19
|
31
|
15
|
15
|
19
|
18
|
14
|
2
|
1
|
|
Overall Study
Continuing to Combo Therapy
|
12
|
11
|
12
|
7
|
10
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Crossing Over to RCC Combo Therapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
1
|
2
|
4
|
1
|
2
|
0
|
0
|
0
|
6
|
2
|
11
|
1
|
1
|
5
|
5
|
0
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
13
|
10
|
8
|
8
|
10
|
9
|
8
|
7
|
12
|
17
|
20
|
14
|
14
|
14
|
13
|
14
|
0
|
1
|
Reasons for withdrawal
| Measure |
P1A 150mg
BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy
|
P1A 300mg
BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy
|
P1A 600mg
BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy
|
P1A 1200mg
BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy
|
P1A 1600mg
BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Monotherapy
BMS-986179 600mg Q2W monotherapy
|
P2 RCC Combo Therapy
BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Disease progression
|
11
|
7
|
8
|
5
|
7
|
7
|
7
|
6
|
11
|
16
|
18
|
13
|
10
|
12
|
12
|
14
|
0
|
1
|
|
Overall Study
Study drug toxicity
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
AE unrelated to study drug
|
1
|
1
|
0
|
1
|
3
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Request to discontinue
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrew consent
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Maximum clinical benefit
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
No longer meets study criteria
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other reasons
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Completed treatment as per protocol
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Not completing monotherapy
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
An Investigational Immuno-therapy Study of Experimental Medication BMS-986179 Given Alone and in Combination With Nivolumab
Baseline characteristics by cohort
| Measure |
P1A 150mg
n=14 Participants
BMS-986179 150mg monotherapy leading into BMS-986179 150mg + Nivo 240 combo therapy
|
P1A 300mg
n=12 Participants
BMS-986179 300mg monotherapy leading into BMS-986179 300mg + Nivo 240mg combo therapy
|
P1A 600mg
n=12 Participants
BMS-986179 600mg monotherapy leading into BMS-986179 600mg + Nivo 240mg combo therapy
|
P1A 1200mg
n=9 Participants
BMS-986179 1200mg monotherapy leading into BMS-986179 1200mg + Nivo 240mg combo therapy
|
P1A 1600mg
n=12 Participants
BMS-986179 1600mg monotherapy leading into BMS-986179 1600mg + Nivo 240mg combo therapy
|
P1B Combo Therapy 150mg
n=9 Participants
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
n=8 Participants
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=7 Participants
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=18 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
n=19 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
n=31 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=19 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 RCC Combo
n=18 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W combo therapy
|
P2 Combo Prostate
n=14 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Unassiged
n=2 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Monotherapy Unassigned
n=1 Participants
BMS-986179 600mg Q2W
|
Total
n=235 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
14 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
6 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
5 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
140 Participants
n=667 Participants
|
|
Age, Categorical
>=65 years
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
5 Participants
n=42 Participants
|
17 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
9 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
9 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
95 Participants
n=667 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
2 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
10 Participants
n=42 Participants
|
9 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
6 Participants
n=36 Participants
|
5 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
87 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
21 Participants
n=42 Participants
|
6 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
13 Participants
n=36 Participants
|
13 Participants
n=24 Participants
|
14 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
148 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
2 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
11 Participants
n=42 Participants
|
11 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
3 Participants
n=42 Participants
|
2 Participants
n=36 Participants
|
12 Participants
n=36 Participants
|
12 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
2 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
92 Participants
n=667 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
7 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
12 Participants
n=36 Participants
|
7 Participants
n=36 Participants
|
6 Participants
n=24 Participants
|
14 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
141 Participants
n=667 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
3 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
8 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
5 Participants
n=667 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
5 Participants
n=24 Participants
|
14 Participants
n=42 Participants
|
19 Participants
n=42 Participants
|
30 Participants
n=42 Participants
|
15 Participants
n=42 Participants
|
14 Participants
n=36 Participants
|
18 Participants
n=36 Participants
|
18 Participants
n=24 Participants
|
13 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
218 Participants
n=667 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
0 Participants
n=667 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=135 Participants
|
1 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: From first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months.Population: All Treated Participants
Number of participants with drug related adverse events (AE), drug related serious adverse events (SAE), drug related AEs Leading to discontinuation and drug related deaths
Outcome measures
| Measure |
P1A 150mg
n=14 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=12 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
n=12 Participants
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=9 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=12 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=7 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=10 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
n=9 Participants
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
n=8 Participants
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=7 Participants
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=18 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
n=19 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
n=31 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
n=18 Participants
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=19 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
n=3 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
n=14 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
n=1 Participants
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
n=2 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Adverse Events
|
7 Participants
|
4 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
5 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
11 Participants
|
21 Participants
|
7 Participants
|
12 Participants
|
15 Participants
|
8 Participants
|
3 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Serious Adverse Events
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
AEs Leading to Discontinuation
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Drug Related AEs, SAEs, AEs Leading to Discontinuation and Deaths.
Deaths
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from initial treatment to week 24Population: All Treated Participants
Best overall response (BOR) is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. CR or PR determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met.
Outcome measures
| Measure |
P1A 150mg
n=14 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=12 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
n=12 Participants
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=9 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=12 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=7 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=10 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
n=9 Participants
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
n=8 Participants
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=7 Participants
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=18 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
n=19 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
n=31 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
n=18 Participants
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=19 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
n=3 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
n=14 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
n=1 Participants
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
n=2 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Best Overall Response (BOR) at Week 24
Complete Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With a Best Overall Response (BOR) at Week 24
Partial Response
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from initial treatment to week 24Population: All Treated Participants
ORR is defined as the percentage of all treated participants whose BOR is either a CR or PR.
Outcome measures
| Measure |
P1A 150mg
n=14 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=12 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
n=12 Participants
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=9 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=12 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=7 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=10 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
n=9 Participants
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
n=8 Participants
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=7 Participants
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=18 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
n=19 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
n=31 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
n=18 Participants
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=19 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
n=3 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
n=14 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
n=1 Participants
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
n=2 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With an Objective Response Rate (ORR) at Week 24
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
0 Percentage of Participants
Insufficient number of participants with events
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
8.3 Percentage of Participants
Interval 0.2 to 38.5
|
9.1 Percentage of Participants
Interval 0.2 to 41.3
|
16.7 Percentage of Participants
Interval 2.1 to 48.4
|
14.3 Percentage of Participants
Interval 0.4 to 57.9
|
10.0 Percentage of Participants
Interval 0.3 to 44.5
|
0 Percentage of Participants
Interval 0.0 to 33.6
|
0 Percentage of Participants
Interval 0.0 to 36.9
|
0 Percentage of Participants
Interval 0.0 to 41.0
|
0 Percentage of Participants
Interval 0.0 to 18.5
|
5.3 Percentage of Participants
Interval 0.1 to 26.0
|
3.2 Percentage of Participants
Interval 0.1 to 16.7
|
0 Percentage of Participants
Interval 0.0 to 21.8
|
13.3 Percentage of Participants
Interval 1.7 to 40.5
|
0 Percentage of Participants
Interval 0.0 to 18.5
|
5.3 Percentage of Participants
Interval 0.1 to 26.0
|
0 Percentage of Participants
Interval 0.0 to 70.8
|
0 Percentage of Participants
Interval 0.0 to 23.2
|
0 Percentage of Participants
Interval 0.0 to 97.5
|
0 Percentage of Participants
Interval 0.0 to 84.2
|
SECONDARY outcome
Timeframe: from initial treatment to week 24Population: All Treated Participants
PFSR at 24 weeks is defined as the percentage of treated participants remaining progression free and surviving at 24 weeks.
Outcome measures
| Measure |
P1A 150mg
n=14 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=12 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
n=12 Participants
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=9 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=12 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=7 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=10 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
n=9 Participants
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
n=8 Participants
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=7 Participants
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=18 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
n=19 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
n=31 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=15 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
n=18 Participants
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=19 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
n=3 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
n=14 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
n=1 Participants
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
n=2 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Progression Free Survival Rate (PFSR) at Week 24
|
7.1 Percentage
Interval 1.3 to 98.7
|
8.3 Percentage
Interval 2.5 to 100.0
|
0 Percentage
Insufficient number of participants with events
|
11.1 Percentage
Interval 1.3 to 98.7
|
16.7 Percentage
Interval 15.8 to 100.0
|
83.3 Percentage
Interval 51.6 to 97.9
|
72.7 Percentage
Interval 39.0 to 94.0
|
75.0 Percentage
Interval 42.8 to 94.5
|
57.1 Percentage
Interval 18.4 to 90.1
|
70.0 Percentage
Interval 34.8 to 93.3
|
88.9 Percentage
Interval 51.8 to 99.7
|
87.5 Percentage
Interval 47.3 to 99.7
|
100.00 Percentage
Interval 59.0 to 100.0
|
88.9 Percentage
Interval 65.3 to 98.6
|
94.7 Percentage
Interval 74.0 to 99.9
|
71.0 Percentage
Interval 52.0 to 85.8
|
86.7 Percentage
Interval 59.5 to 98.3
|
80.0 Percentage
Interval 51.9 to 95.7
|
72.2 Percentage
Interval 46.5 to 90.3
|
42.1 Percentage
Interval 20.3 to 66.5
|
66.7 Percentage
Interval 9.4 to 99.2
|
71.4 Percentage
Interval 41.9 to 91.6
|
100.0 Percentage
Interval 2.5 to 100.0
|
50.0 Percentage
Interval 1.3 to 98.7
|
SECONDARY outcome
Timeframe: from first measure response approximately up to 25 monthsPopulation: All Treated Participants with a response
DOR (computed for all treated subjects with a BOR of CR or PR) is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first.
Outcome measures
| Measure |
P1A 150mg
BMS-986179 150mg monotherapy
|
P1A 300mg
BMS-986179 300mg monotherapy
|
P1A 600mg
BMS-986179 600mg monotherapy
|
P1A 1200mg
BMS-986179 1200mg monotherapy
|
P1A 1600mg
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=1 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=1 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=2 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=1 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=1 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
n=1 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
n=1 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=2 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=1 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Median Duration of Response (DOR)
|
—
|
—
|
—
|
—
|
—
|
17.40 Months
Interval 17.4 to 17.4
|
5.70 Months
Interval 5.7 to 5.7
|
9.30 Months
Interval 7.2 to 11.4
|
2.10 Months
Interval 2.1 to 2.1
|
24.40 Months
Interval 24.4 to 24.4
|
—
|
—
|
—
|
—
|
3.90 Months
Interval 3.9 to 3.9
|
3.80 Months
Interval 3.8 to 3.8
|
—
|
6.70 Months
Interval 3.8 to 9.6
|
—
|
22.90 Months
Interval 22.9 to 22.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysPopulation: All Treated Participants with evaluable cmax measurements at specified time points
Cmax is defined as maximum plasma concentration of the drug
Outcome measures
| Measure |
P1A 150mg
n=2 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=1 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=2 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=2 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=6 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=8 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=17 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=15 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cmax
Cycle 0 Day 1
|
30.6524 ug/mL
Geometric Coefficient of Variation 66
|
94.9210 ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
218.0423 ug/mL
Geometric Coefficient of Variation 8
|
499.5178 ug/mL
Geometric Coefficient of Variation 10
|
28.8892 ug/mL
Geometric Coefficient of Variation 25
|
64.3400 ug/mL
Geometric Coefficient of Variation 55
|
141.3732 ug/mL
Geometric Coefficient of Variation 26
|
315.6963 ug/mL
Geometric Coefficient of Variation 16
|
453.5664 ug/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax
Cycle 1 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
93.7415 ug/mL
Geometric Coefficient of Variation 33
|
—
|
—
|
—
|
—
|
—
|
142.9541 ug/mL
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
—
|
|
Cmax
Cycle 1 Day 22
|
—
|
—
|
—
|
—
|
—
|
51.3637 ug/mL
Geometric Coefficient of Variation 38
|
99.3564 ug/mL
Geometric Coefficient of Variation 47
|
289.8829 ug/mL
Geometric Coefficient of Variation 27
|
722.2768 ug/mL
Geometric Coefficient of Variation 32
|
865.8497 ug/mL
Geometric Coefficient of Variation 22
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
563.4487 ug/mL
Geometric Coefficient of Variation 27
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Cmax
Cycle 4 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
246.7860 ug/mL
Geometric Coefficient of Variation 41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysPopulation: All Treated Participants with evaluable tmax measurements at specified time points
Tmax is defined is the time to maximum plasma concentration
Outcome measures
| Measure |
P1A 150mg
n=2 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=1 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=2 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=2 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=10 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=6 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=8 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=17 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=15 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Tmax
Cycle 0 Day 1
|
2.409 hours
Interval 0.8 to 4.017
|
0.933 hours
Interval 0.933 to 0.933
|
—
|
2.992 hours
Interval 1.983 to 4.0
|
2.700 hours
Interval 2.4 to 3.0
|
1.00 hours
Interval 0.967 to 8.25
|
2.942 hours
Interval 0.967 to 8.0
|
1.109 hours
Interval 0.867 to 24.05
|
4.000 hours
Interval 1.967 to 8.0
|
3.692 hours
Interval 1.783 to 24.117
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax
Cycle 1 Day 22
|
—
|
—
|
—
|
—
|
—
|
4.000 hours
Interval 0.967 to 9.05
|
7.767 hours
Interval 4.067 to 95.95
|
4.000 hours
Interval 0.967 to 7.933
|
8.000 hours
Interval 2.1 to 10.05
|
4.000 hours
Interval 1.983 to 8.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax
Cycle 1 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
96.200 hours
Interval 48.017 to 168.267
|
—
|
—
|
—
|
—
|
—
|
4.000 hours
Interval 0.967 to 9.0
|
—
|
—
|
—
|
—
|
|
Tmax
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
4.000 hours
Interval 1.967 to 24.667
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Tmax
Cycle 4 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
1.275 hours
Interval 0.67 to 22.883
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysPopulation: All Treated Participants with evaluable AUC (0-T) measurements at specified time points
Area under the plasma concentration time-curve. AUC from time 0 to the last time of quantifiable concentration
Outcome measures
| Measure |
P1A 150mg
n=2 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=1 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=2 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=2 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=6 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=8 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=17 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=15 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (0-T)
Cycle 0 Day 1
|
1417.4834 h*ug/mL
Geometric Coefficient of Variation 76
|
2565.0489 h*ug/mL
Geometric Coefficient of Variation NA
Insufficient number of participants to calculate
|
—
|
9362.9155 h*ug/mL
Geometric Coefficient of Variation 39
|
30716.0037 h*ug/mL
Geometric Coefficient of Variation 47
|
1225.3679 h*ug/mL
Geometric Coefficient of Variation 36
|
3418.8393 h*ug/mL
Geometric Coefficient of Variation 62
|
9139.4853 h*ug/mL
Geometric Coefficient of Variation 30
|
23533.0706 h*ug/mL
Geometric Coefficient of Variation 9
|
31057.8588 h*ug/mL
Geometric Coefficient of Variation 26
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0-T)
Cycle 1 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
41672.2787 h*ug/mL
Geometric Coefficient of Variation 35
|
—
|
—
|
—
|
—
|
—
|
13372.5460 h*ug/mL
Geometric Coefficient of Variation 55
|
—
|
—
|
—
|
—
|
|
AUC (0-T)
Cycle 1 Day 22
|
—
|
—
|
—
|
—
|
—
|
3932.5889 h*ug/mL
Geometric Coefficient of Variation 44
|
9622.5237 h*ug/mL
Geometric Coefficient of Variation 58
|
27616.4807 h*ug/mL
Geometric Coefficient of Variation 40
|
74405.3428 h*ug/mL
Geometric Coefficient of Variation 25
|
92340.2959 h*ug/mL
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0-T)
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
84384.9379 h*ug/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC (0-T)
Cycle 4 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
28348.0936 h*ug/mL
Geometric Coefficient of Variation 74
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysPopulation: All Treated Participants with evaluable AUC (Tau) measurements at specified time points
Area under the plasma concentration time-curve. AUC over the dosing interval.
Outcome measures
| Measure |
P1A 150mg
n=2 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
BMS-986179 300mg monotherapy
|
P1A 600mg
BMS-986179 600mg monotherapy
|
P1A 1200mg
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=2 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=6 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=8 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=16 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=11 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
AUC (Tau)
Cycle 0 Day 1
|
1417.4834 h*ug/mL
Geometric Coefficient of Variation 76
|
—
|
—
|
—
|
34198.6293 h*ug/mL
Geometric Coefficient of Variation 33
|
1307.7132 h*ug/mL
Geometric Coefficient of Variation 33
|
3546.1659 h*ug/mL
Geometric Coefficient of Variation 59
|
9139.4853 h*ug/mL
Geometric Coefficient of Variation 30
|
23533.0706 h*ug/mL
Geometric Coefficient of Variation 9
|
34970.3626 h*ug/mL
Geometric Coefficient of Variation 12
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC (Tau)
Cycle 1 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
40833.1977 h*ug/mL
Geometric Coefficient of Variation 36
|
—
|
—
|
—
|
—
|
—
|
15774.5137 h*ug/mL
Geometric Coefficient of Variation 49
|
—
|
—
|
—
|
—
|
|
AUC (Tau)
Cycle 1 Day 22
|
—
|
—
|
—
|
—
|
—
|
3975.0900 h*ug/mL
Geometric Coefficient of Variation 46
|
12326.2351 h*ug/mL
Geometric Coefficient of Variation 44
|
30044.3813 h*ug/mL
Geometric Coefficient of Variation 35
|
74405.3428 h*ug/mL
Geometric Coefficient of Variation 25
|
92340.2959 h*ug/mL
Geometric Coefficient of Variation 21
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC (Tau)
Cycle 2 Day 1
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
92770.2634 h*ug/mL
Geometric Coefficient of Variation 30
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
AUC (Tau)
Cycle 4 Day 15
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
45391.3244 h*ug/mL
Geometric Coefficient of Variation 55
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Part 1A Cycle 0 = 14 days Cycle 1 = 28 days Part 1B and Part 2 Q2W regimen Cycle 0 = 14 days Cycle 1 = 28 days Cycle 2 = 28 days Part 1B and 2 Q4W Regimen Cycle 1= 28 days Cycle 2 = 28 days Cycle 4 = 28 daysPopulation: All Treated Participants with evaluable Ctau measurements at specified time points
Ctau is defined as the concentration of study drug at the end of the dosing interval
Outcome measures
| Measure |
P1A 150mg
n=2 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
BMS-986179 300mg monotherapy
|
P1A 600mg
BMS-986179 600mg monotherapy
|
P1A 1200mg
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=2 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=12 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=10 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=6 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=7 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=16 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=11 Participants
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Ctau
Cycle 0 Day 1
|
1.9173 ug/mL
Geometric Coefficient of Variation 99
|
—
|
—
|
—
|
82.2225 ug/mL
Geometric Coefficient of Variation 82
|
0.8999 ug/mL
Geometric Coefficient of Variation 74
|
41.0567 ug/mL
Geometric Coefficient of Variation 84
|
25.9755 ug/mL
Geometric Coefficient of Variation 32
|
74.8859 ug/mL
Geometric Coefficient of Variation 30
|
99.0307 ug/mL
Geometric Coefficient of Variation 14
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Ctau
Cycle 1 Day 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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30.0008 ug/mL
Geometric Coefficient of Variation 51
|
—
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—
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—
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—
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—
|
15.3394 ug/mL
Geometric Coefficient of Variation 76
|
—
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—
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—
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—
|
|
Ctau
Cycle 1 Day 22
|
—
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—
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—
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—
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—
|
14.5545 ug/mL
Geometric Coefficient of Variation 54
|
51.0567 ug/mL
Geometric Coefficient of Variation 44
|
126.4960 ug/mL
Geometric Coefficient of Variation 37
|
366.8165 ug/mL
Geometric Coefficient of Variation 21
|
466.5231 ug/mL
Geometric Coefficient of Variation 32
|
—
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—
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—
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—
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—
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—
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—
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Ctau
Cycle 2 Day 1
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
52.9049 ug/mL
Geometric Coefficient of Variation 71
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
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Ctau
Cycle 4 Day 15
|
—
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—
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—
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—
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—
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—
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—
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—
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—
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—
|
98.6089 ug/mL
Geometric Coefficient of Variation 76
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: approximately up to 95 weeksPopulation: All Treated Participants with evaluable CD73 assay measurements for each assay
Mean change from baseline in CD73 assays at the end of Part 1A treatment period Assays Measured: EHC CD73 H-score IHC CD73 Cytoplasm H-Score IHC CDS73 Membrane H-Score The H-score is given by the ratio of the weighted sum of the number of positive cells to the total number of detected cells. The H-score captures both the intensity and the proportion of the biomarker of interest from the IHC image and comprises values between 0 and 300. The lower the number equals a better prognosis.
Outcome measures
| Measure |
P1A 150mg
n=4 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=3 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=1 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=2 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=4 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=3 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=1 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=2 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Mean Change From Baseline in CD73 Assays
EHC CD73 H-Score
|
-33.790 Score on a scale
Standard Error 25.5200
|
-103.700 Score on a scale
Standard Error 90.3400
|
—
|
-204.710 Score on a scale
Standard Error NA
Insufficient number of participants to evaluate
|
-3.220 Score on a scale
Standard Error 51.7800
|
-33.790 Score on a scale
Standard Error 28.5200
|
-103.700 Score on a scale
Standard Error 90.3400
|
—
|
-204.710 Score on a scale
Standard Error NA
Insufficient number of participants to evaluate
|
-3.220 Score on a scale
Standard Error 51.7800
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in CD73 Assays
IHC CD73 Cytoplasm H-Score
|
1.5 Score on a scale
Standard Error 2.60
|
-0.3 Score on a scale
Standard Error 32.04
|
—
|
17.0 Score on a scale
Standard Error NA
Insufficient number of participants to evaluate
|
0.0 Score on a scale
Standard Error 0.00
|
1.5 Score on a scale
Standard Error 2.60
|
-0.3 Score on a scale
Standard Error 32.04
|
—
|
17.0 Score on a scale
Standard Error NA
Insufficient number of participants to evaluate
|
0.0 Score on a scale
Standard Error 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Mean Change From Baseline in CD73 Assays
IHC CD73 Membrane H-Score
|
7.3 Score on a scale
Standard Error 6.77
|
8.7 Score on a scale
Standard Error 30.33
|
—
|
88.0 Score on a scale
Standard Error NA
Insufficient number of participants to evaluate
|
0.00 Score on a scale
Standard Error 0.00
|
7.3 Score on a scale
Standard Error 6.77
|
8.7 Score on a scale
Standard Error 30.33
|
—
|
88.0 Score on a scale
Standard Error NA
Insufficient number of participants to evaluate
|
0.0 Score on a scale
Standard Error 0.00
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to last dose: Part 1: up to 95 weeks, Part 2 SC: up to 62 weeks, RCC Mono: up to 108 weeks, Part 2: up to 104 weeksPopulation: All Treated Participants with evaluable ADA measurements
A participant with at least one ADA-positive sample relative to baseline at any time after initiation of treatment with BMS-986179 and nivolumab.
Outcome measures
| Measure |
P1A 150mg
n=14 Participants
BMS-986179 150mg monotherapy
|
P1A 300mg
n=12 Participants
BMS-986179 300mg monotherapy
|
P1A 600mg
n=12 Participants
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=9 Participants
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=12 Participants
BMS-986179 1600mg monotherapy
|
P1A Combo Therapy 150mg
n=9 Participants
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=8 Participants
BMS-986179 300mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=7 Participants
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=18 Participants
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=19 Participants
BMS-986179 1600mg + Nivo 240mg
|
P1B Combo Therapy 150mg
n=31 Participants
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 360mg
n=15 Participants
BMS-986179 1200mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=15 Participants
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS986-179 1600mg
n=18 Participants
BMS-986179 1600mg SC
|
P2 Combo Pancreatic
n=18 Participants
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo Therapy NSCLC
n=3 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=14 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=1 Participants
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
n=2 Participants
BMS986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
BMS-986179 600mg Q2W monotherapy
|
P2 Combo RCC Crossover
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
BMS-986179 600mg Q2W
|
P2 Combo Unassiged
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
BMS-986179 ADA+
|
5 Participants
|
4 Participants
|
8 Participants
|
3 Participants
|
2 Participants
|
5 Participants
|
6 Participants
|
5 Participants
|
11 Participants
|
9 Participants
|
22 Participants
|
9 Participants
|
6 Participants
|
14 Participants
|
13 Participants
|
2 Participants
|
8 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With a Positive Anti-drug Antibody (ADA) Test.
Nivolumab ADA+
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
P1A 150mg
Serious events: 3 serious events
Other events: 11 other events
Deaths: 2 deaths
P1A 300mg
Serious events: 4 serious events
Other events: 8 other events
Deaths: 1 deaths
P1A 600mg
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
P1A 1200mg
Serious events: 2 serious events
Other events: 6 other events
Deaths: 2 deaths
P1A 1600mg
Serious events: 3 serious events
Other events: 12 other events
Deaths: 2 deaths
P1A All Mono
Serious events: 13 serious events
Other events: 45 other events
Deaths: 7 deaths
P1A Combo Therapy 150mg
Serious events: 5 serious events
Other events: 11 other events
Deaths: 9 deaths
P1A Combo Therapy 300mg
Serious events: 6 serious events
Other events: 11 other events
Deaths: 11 deaths
P1A Combo Therapy 600mg
Serious events: 9 serious events
Other events: 12 other events
Deaths: 11 deaths
P1A Combo Therapy 1200mg
Serious events: 3 serious events
Other events: 7 other events
Deaths: 6 deaths
P1A Combo Therapy 1600mg
Serious events: 5 serious events
Other events: 9 other events
Deaths: 8 deaths
P1A All Combo
Serious events: 28 serious events
Other events: 50 other events
Deaths: 45 deaths
P1B Combo Therapy 150mg
Serious events: 7 serious events
Other events: 9 other events
Deaths: 9 deaths
P1B Combo Therapy BMS-986179 1200mg + Nivo360mg
Serious events: 7 serious events
Other events: 6 other events
Deaths: 8 deaths
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
Serious events: 4 serious events
Other events: 6 other events
Deaths: 5 deaths
P1B BMS-986179 1600mg
Serious events: 11 serious events
Other events: 17 other events
Deaths: 18 deaths
P1B All Combo
Serious events: 18 serious events
Other events: 21 other events
Deaths: 22 deaths
P2 Combo Pancreatic
Serious events: 8 serious events
Other events: 17 other events
Deaths: 14 deaths
P2 Combo NSCLC
Serious events: 14 serious events
Other events: 31 other events
Deaths: 23 deaths
P2 Combo Melanoma
Serious events: 8 serious events
Other events: 14 other events
Deaths: 14 deaths
P2 Combo SCCHN
Serious events: 11 serious events
Other events: 14 other events
Deaths: 13 deaths
P2 RCC Combo
Serious events: 11 serious events
Other events: 17 other events
Deaths: 9 deaths
P2 RCC Mono
Serious events: 5 serious events
Other events: 19 other events
Deaths: 8 deaths
P2 RCC Crossover
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
P2 Combo Prostate
Serious events: 4 serious events
Other events: 13 other events
Deaths: 13 deaths
P2 Monotherapy Unassigned
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
P2 Combo Unassigned
Serious events: 0 serious events
Other events: 1 other events
Deaths: 1 deaths
P2 All Combo Therapy
Serious events: 57 serious events
Other events: 110 other events
Deaths: 88 deaths
ALL Combo (P1A+P1B+P2)
Serious events: 103 serious events
Other events: 181 other events
Deaths: 155 deaths
Serious adverse events
| Measure |
P1A 150mg
n=14 participants at risk
BMS-986179 150mg monotherapy
|
P1A 300mg
n=12 participants at risk
BMS-986179 300mg monotherapy
|
P1A 600mg
n=12 participants at risk
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=9 participants at risk
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=12 participants at risk
BMS-986179 1600mg monotherapy
|
P1A All Mono
n=59 participants at risk
P1A all treated participants in monotherapy
|
P1A Combo Therapy 150mg
n=12 participants at risk
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 participants at risk
BMS-986179 3000mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 participants at risk
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=7 participants at risk
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=10 participants at risk
BMS-986179 1600mg + Nivo 240mg
|
P1A All Combo
n=52 participants at risk
P1A all treated participants in combo therapy
|
P1B Combo Therapy 150mg
n=9 participants at risk
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo360mg
n=8 participants at risk
BMS-986179 1200mg + Nivo360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=7 participants at risk
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS-986179 1600mg
n=18 participants at risk
BMS-986179 1600mg SC
|
P1B All Combo
n=24 participants at risk
All treated participants in P1B combo therapy period
|
P2 Combo Pancreatic
n=19 participants at risk
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo NSCLC
n=31 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=15 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=15 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
n=18 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=19 participants at risk
BMS-986179 600mg Q2W Monotherapy
|
P2 RCC Crossover
n=3 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
n=14 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
n=1 participants at risk
BMS-986179 600mg Q2W
|
P2 Combo Unassigned
n=2 participants at risk
BMS-986179 1200mg Q2W + Nivo 480mg Q4W
|
P2 All Combo Therapy
n=117 participants at risk
All Treated participants in the P2 treatment period
|
ALL Combo (P1A+P1B+P2)
n=193 participants at risk
All treated participants in P1A, P1B and P2 combo therapy periods
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Spinal cord infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Urosepsis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Haemolysis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Myocardial infarction
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Subileus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
General physical health deterioration
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Oedema peripheral
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Performance status decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Biliary obstruction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Abdominal infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Biliary tract infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Infusion site infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Pericarditis infective
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Perinephric abscess
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Liver function test increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Transaminases increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Weight decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.1%
6/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
4/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
36.4%
4/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
13/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
3/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
4/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
37.5%
9/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
42.1%
8/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
40.0%
6/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
5/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
23.1%
27/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.4%
49/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Carotid artery dissection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Syncope
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Product Issues
Device malfunction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Delirium
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
6/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal necrosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
Other adverse events
| Measure |
P1A 150mg
n=14 participants at risk
BMS-986179 150mg monotherapy
|
P1A 300mg
n=12 participants at risk
BMS-986179 300mg monotherapy
|
P1A 600mg
n=12 participants at risk
BMS-986179 600mg monotherapy
|
P1A 1200mg
n=9 participants at risk
BMS-986179 1200mg monotherapy
|
P1A 1600mg
n=12 participants at risk
BMS-986179 1600mg monotherapy
|
P1A All Mono
n=59 participants at risk
P1A all treated participants in monotherapy
|
P1A Combo Therapy 150mg
n=12 participants at risk
BMS-986179 150mg + Nivo 240mg
|
P1A Combo Therapy 300mg
n=11 participants at risk
BMS-986179 3000mg + Nivo 240mg
|
P1A Combo Therapy 600mg
n=12 participants at risk
BMS-986179 600mg + Nivo 240mg
|
P1A Combo Therapy 1200mg
n=7 participants at risk
BMS-986179 1200mg + Nivo 240mg
|
P1A Combo Therapy 1600mg
n=10 participants at risk
BMS-986179 1600mg + Nivo 240mg
|
P1A All Combo
n=52 participants at risk
P1A all treated participants in combo therapy
|
P1B Combo Therapy 150mg
n=9 participants at risk
BMS-986179 150mg + Nivo 360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo360mg
n=8 participants at risk
BMS-986179 1200mg + Nivo360mg
|
P1B Combo Therapy BMS-986179 1200mg + Nivo 480mg
n=7 participants at risk
BMS-986179 1200mg + Nivo 480mg
|
P1B BMS-986179 1600mg
n=18 participants at risk
BMS-986179 1600mg SC
|
P1B All Combo
n=24 participants at risk
All treated participants in P1B combo therapy period
|
P2 Combo Pancreatic
n=19 participants at risk
BMS-986179 1200mg Q2W + Nivo 240mg Q2W
|
P2 Combo NSCLC
n=31 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Melanoma
n=15 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo SCCHN
n=15 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Combo
n=18 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 RCC Mono
n=19 participants at risk
BMS-986179 600mg Q2W Monotherapy
|
P2 RCC Crossover
n=3 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Combo Prostate
n=14 participants at risk
BMS-986179 600mg Q2W + Nivo 480mg Q4W
|
P2 Monotherapy Unassigned
n=1 participants at risk
BMS-986179 600mg Q2W
|
P2 Combo Unassigned
n=2 participants at risk
BMS-986179 1200mg Q2W + Nivo 480mg Q4W
|
P2 All Combo Therapy
n=117 participants at risk
All Treated participants in the P2 treatment period
|
ALL Combo (P1A+P1B+P2)
n=193 participants at risk
All treated participants in P1A, P1B and P2 combo therapy periods
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.3%
9/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
27.3%
3/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
17.3%
9/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
37.5%
3/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.8%
5/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
29.0%
9/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
66.7%
2/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.4%
25/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.2%
39/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Splenic vein thrombosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Mitral valve disease
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Palpitations
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Sinoatrial block
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Sinus bradycardia
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Ear and labyrinth disorders
Middle ear effusion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.2%
2/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.6%
5/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.7%
11/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Amaurosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Conjunctival oedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Diplopia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Dry eye
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Eye disorder
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Eye irritation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Eye oedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Eye pruritus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Periorbital oedema
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Vision blurred
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Abdominal distension
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
2/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.5%
5/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.5%
7/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
2/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
38.9%
7/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
4/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.4%
11/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.4%
22/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.0%
7/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.7%
11/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Anal erythema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
36.8%
7/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.0%
7/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.2%
10/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
4/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.2%
11/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
3/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
42.9%
3/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
29.2%
7/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.1%
5/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
4/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.2%
19/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.2%
37/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Diarrhoea
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.2%
6/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
6/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
42.9%
3/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.9%
14/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
4/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
29.0%
9/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.7%
4/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
38.9%
7/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
31.6%
6/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
66.7%
2/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
23.1%
27/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
23.3%
45/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.5%
6/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
3/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
6/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.8%
15/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Epigastric discomfort
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.2%
6/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
63.6%
7/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.8%
15/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
3/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
27.8%
5/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
4/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
66.7%
2/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.5%
17/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.7%
36/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.2%
6/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
45.5%
5/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
30.0%
3/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
23.1%
12/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.4%
11/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.5%
26/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Asthenia
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
4/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
40.0%
4/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.4%
8/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
2/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
4/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.3%
5/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
45.2%
14/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
5/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
47.4%
9/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.6%
30/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.8%
42/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Axillary pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Catheter site pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Chest discomfort
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Chest pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Chills
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Device related thrombosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Discomfort
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Early satiety
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Face oedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Facial pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Fatigue
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
4/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
36.4%
4/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.9%
14/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
44.4%
4/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
71.4%
5/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
9/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
41.7%
10/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
31.6%
6/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.4%
6/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
60.0%
9/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
66.7%
2/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
4/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
27.4%
32/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
29.0%
56/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Feeling cold
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Gait disturbance
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Generalised oedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Hyperthermia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Inflammation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Influenza like illness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Infusion site joint swelling
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Injection site reaction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Localised oedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Malaise
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Mucosal inflammation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.1%
6/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
8/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.7%
11/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Oedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Oedema peripheral
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
45.5%
5/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
71.4%
5/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
30.0%
3/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
36.5%
19/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
37.5%
3/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.8%
5/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.3%
5/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.2%
19/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.3%
43/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.5%
10/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.2%
12/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Peripheral swelling
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Pyrexia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
41.7%
5/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.2%
10/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
6/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.3%
12/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.4%
24/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
General disorders
Xerosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Jaundice
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Bronchitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Ear infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Fungal infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Furuncle
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Influenza
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Laryngitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Localised infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Mucosal infection
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Nail infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Nasal herpes
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Oral infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Otitis externa
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Periodontitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.7%
4/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Propionibacterium infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Purulent discharge
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Renal abscess
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Skin infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Tooth infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.0%
7/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.2%
12/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Viral infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
6/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Post procedural pruritus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Stoma site pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Vascular access site pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Vascular access site rash
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Ammonia increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Amylase decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Amylase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.1%
5/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.0%
7/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.7%
11/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.3%
5/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
9/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
13/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood alkaline phosphatase decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
8/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.2%
10/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood creatine phosphokinase MB increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.1%
6/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.1%
5/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
8/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
13/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood glucose decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood iron decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.4%
6/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
8/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.7%
9/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood pressure increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood triglycerides abnormal
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood triglycerides increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood urea increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood uric acid increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Blood urine present
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.4%
6/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.5%
10/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.2%
12/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Haemoglobin increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Heart rate decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Heart rate increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Immature granulocyte count increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
International normalised ratio increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Lipase decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Lipase increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.8%
8/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.0%
14/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.8%
19/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Liver function test increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Lymphocyte percentage decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Monocyte count increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Neutrophil count increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Neutrophil percentage increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Protein total decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Red blood cell count decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Red blood cell sedimentation rate decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Transaminases increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Tri-iodothyronine free decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Troponin I increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Weight decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
66.7%
2/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
9/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
16/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
Weight increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
White blood cell count increased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Investigations
White blood cells urine positive
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
6/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.2%
11/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
3/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
6/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
31.6%
6/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.1%
5/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.3%
5/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
66.7%
2/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
17.9%
21/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.1%
35/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.7%
9/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.2%
10/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.8%
8/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.4%
11/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.7%
11/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.8%
8/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
8/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.7%
9/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.1%
5/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.6%
7/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
8/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.4%
6/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.3%
12/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
16/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.2%
2/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.5%
6/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
6/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.2%
12/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.4%
6/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.3%
12/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
16/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
2/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
2/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.0%
7/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.2%
12/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.2%
2/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
19.2%
10/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
27.8%
5/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.9%
4/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.4%
3/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.0%
14/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.0%
25/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
40.0%
4/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
17.3%
9/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
3/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
2/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
29.2%
7/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
66.7%
2/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.3%
12/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.5%
28/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.6%
5/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.7%
9/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
2/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.2%
2/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.7%
4/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
13/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.8%
17/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
2/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.6%
5/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.4%
11/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
16/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Sarcopenia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm malignant
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.2%
2/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
4/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
6/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.7%
9/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Amnesia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Aphasia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Central nervous system mass
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.1%
6/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
2/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.3%
9/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.5%
10/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
16/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Ophthalmic migraine
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Presyncope
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Sciatica
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Seizure
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Somnolence
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Product Issues
Device dislocation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
30.0%
3/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.7%
4/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
2/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
6/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.2%
12/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
2/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.2%
2/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.5%
7/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
13/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Bladder spasm
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Leukocyturia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Pollakiuria
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Strangury
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Reproductive system and breast disorders
Balanoposthitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Reproductive system and breast disorders
Testis discomfort
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
3/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
4/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
3/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
5/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.9%
14/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.1%
4/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
29.0%
9/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.8%
22/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.2%
39/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
4/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
27.3%
3/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
42.9%
3/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
30.0%
3/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
13/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
25.0%
2/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
4/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
4/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.3%
5/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
35.5%
11/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
26.3%
5/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.4%
3/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.2%
26/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
22.3%
43/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.6%
5/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
1/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
5/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.1%
4/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
2/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.8%
3/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.1%
6/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.2%
10/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
2/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
50.0%
1/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
2/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
2/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
18.2%
2/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.6%
5/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
3/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
12.5%
3/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
15.8%
3/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.7%
3/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
21.4%
3/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.5%
17/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.0%
25/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
28.6%
2/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.6%
5/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
2/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.8%
8/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
13/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.2%
1/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
13.3%
2/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.4%
4/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin fragility
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
14.3%
1/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin hypopigmentation
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin induration
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Embolism
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Flushing
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Haematoma
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Hot flush
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
33.3%
1/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
2.6%
3/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.6%
3/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.0%
1/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.8%
2/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.2%
1/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
16.7%
3/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
7.1%
1/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
100.0%
1/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.3%
5/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
3.6%
7/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
11.1%
1/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
1/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
8.3%
1/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
10.5%
2/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
20.0%
3/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.0%
7/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
4.1%
8/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Inferior vena cava stenosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.7%
1/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
9.1%
1/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.9%
1/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
6.5%
2/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.7%
2/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
1.0%
2/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Thrombosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Vasculitis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Vena cava thrombosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.6%
1/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/59 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/11 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/12 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/10 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/52 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/9 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/8 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/7 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/24 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
5.3%
1/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/31 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/15 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/18 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/19 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/3 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/14 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/1 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.00%
0/2 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.85%
1/117 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
0.52%
1/193 • Serious adverse events and other adverse events will be measured from first dose to 100 days post last dose: Part 1 up to 25.1 months, Part 2 SC up to 17.5 months, RCC Mono up to 28.1 months, Part 2 up to 27.2 months. All-cause mortality will be measured from randomization to study completion: approximately up to 5 years and 4 months
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please Email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60