Trial Outcomes & Findings for A Phase Ib/II Multicenter Open-label Study of Bemcentinib (BGB324) in Patients With AML or MDS (NCT NCT02488408)
NCT ID: NCT02488408
Last Updated: 2024-12-19
Results Overview
If 1 participant in a cohort experienced a dose limiting toxicity (DLT) during Cycle 1, the cohort was expanded to 6 participants. If 2 of 3 or 2 of 6 participants in a cohort experience DLT no further dose escalation took place and the dose below was nominated as the MTD. DLT was assessed during the first 3 weeks of treatment (Cycle 1) with bemcentinib. DLT was defined as according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) \[NCI CTCAE\] version 4, considered unrelated to leukemia progression or intercurrent illness.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
122 participants
Primary outcome timeframe
Cycle 1 (21 days)
Results posted on
2024-12-19
Participant Flow
A total of 122 participants were enrolled to the study and received study treatment.
Participant milestones
| Measure |
Part A: Bemcentinib 400/100 Milligram (mg)
Participants with relapsed or refractory acute myeloid leukemia (AML) who received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 100 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 568 days.
|
Part A: Bemcentinib 600/200 mg
Participants with relapsed or refractory AML initially received loading dose of bemcentinib 600 mg on Days 1 and 2. However, following the report of DLTs, subjects received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 126 days. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Part A: Bemcentinib 900/300 mg
Participants with relapsed or refractory AML initially received loading dose of bemcentinib 900 mg on Days 1 and 2. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 122 days. Hence, some participants received 900 mg and some received 400 mg of bemcentinib as loading dose.
|
Part A: Bemcentinib 200/100 mg
Participants with relapsed or refractory AML received daily loading dose of bemcentinib 200 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 100 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 68 days.
|
Part A: Bemcentinib 400/200 mg
Participants with relapsed or refractory AML who received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 717 days.
|
Part B1: Bemcentinib 400/200 mg
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg
Participants with previously treated myelodysplastic syndrome (MDS) (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
STARTED
|
6
|
14
|
5
|
4
|
7
|
0
|
0
|
0
|
0
|
0
|
|
Part A
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
NOT COMPLETED
|
6
|
14
|
5
|
4
|
7
|
0
|
0
|
0
|
0
|
0
|
|
Part B
STARTED
|
0
|
0
|
0
|
0
|
0
|
14
|
16
|
18
|
18
|
20
|
|
Part B
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
14
|
16
|
18
|
18
|
20
|
Reasons for withdrawal
| Measure |
Part A: Bemcentinib 400/100 Milligram (mg)
Participants with relapsed or refractory acute myeloid leukemia (AML) who received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 100 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 568 days.
|
Part A: Bemcentinib 600/200 mg
Participants with relapsed or refractory AML initially received loading dose of bemcentinib 600 mg on Days 1 and 2. However, following the report of DLTs, subjects received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 126 days. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Part A: Bemcentinib 900/300 mg
Participants with relapsed or refractory AML initially received loading dose of bemcentinib 900 mg on Days 1 and 2. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 122 days. Hence, some participants received 900 mg and some received 400 mg of bemcentinib as loading dose.
|
Part A: Bemcentinib 200/100 mg
Participants with relapsed or refractory AML received daily loading dose of bemcentinib 200 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 100 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 68 days.
|
Part A: Bemcentinib 400/200 mg
Participants with relapsed or refractory AML who received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 717 days.
|
Part B1: Bemcentinib 400/200 mg
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg
Participants with previously treated myelodysplastic syndrome (MDS) (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A
Adverse Event
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Death
|
1
|
5
|
0
|
0
|
3
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Disease Progression
|
2
|
8
|
2
|
3
|
4
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Initiation of Alternative Cancer Therapy
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Investigator Decision
|
0
|
1
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Withdrawal by Subject
|
0
|
0
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part A
Other
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Part B
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
7
|
2
|
2
|
|
Part B
Death
|
0
|
0
|
0
|
0
|
0
|
3
|
1
|
2
|
2
|
2
|
|
Part B
Death due to Disease Progression
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
1
|
1
|
1
|
|
Part B
Disease Progression
|
0
|
0
|
0
|
0
|
0
|
6
|
9
|
7
|
9
|
11
|
|
Part B
Initiation of Alternative Cancer Therapy
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
1
|
2
|
3
|
|
Part B
Investigator Decision
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
2
|
1
|
Baseline Characteristics
A Phase Ib/II Multicenter Open-label Study of Bemcentinib (BGB324) in Patients With AML or MDS
Baseline characteristics by cohort
| Measure |
Part A: Bemcentinib 400/100 mg
n=6 Participants
Participants with relapsed or refractory AML who received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 100 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 568 days.
|
Part A: Bemcentinib 600/200 mg
n=14 Participants
Participants with relapsed or refractory AML initially received loading dose of bemcentinib 600 mg on Days 1 and 2. However, following the report of DLTs, subjects received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 126 days. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Part A: Bemcentinib 900/300 mg
n=5 Participants
Participants with relapsed or refractory AML initially received loading dose of bemcentinib 900 mg on Days 1 and 2. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 122 days. Hence, some participants received 900 mg and some received 400 mg of bemcentinib as loading dose.
|
Part A: Bemcentinib 200/100 mg
n=4 Participants
Participants with relapsed or refractory AML received daily loading dose of bemcentinib 200 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 100 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 68 days.
|
Part A: Bemcentinib 400/200 mg
n=7 Participants
Participants with relapsed or refractory AML who received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 717 days.
|
Part B1: Bemcentinib 400/200 mg, AML 400/200 mg Single Agent
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=16 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: BGB324 400/200 mg + Decitabine, AML
n=18 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: BGB324 400/200 mg, MDS
n=18 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: BGB324 400/200 mg + Cytarabine, AML
n=20 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Total
n=122 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
<75 years
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
7 Participants
n=42 Participants
|
48 Participants
n=42 Participants
|
|
Age, Customized
>= 75 years
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
15 Participants
n=24 Participants
|
9 Participants
n=42 Participants
|
13 Participants
n=42 Participants
|
74 Participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=24 Participants
|
8 Participants
n=42 Participants
|
8 Participants
n=42 Participants
|
44 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
10 Participants
n=42 Participants
|
12 Participants
n=42 Participants
|
78 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
15 Participants
n=8 Participants
|
18 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
120 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
2 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
14 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
17 Participants
n=42 Participants
|
20 Participants
n=42 Participants
|
119 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
1 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
1 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Cycle 1 (21 days)Population: The safety analysis population in Part A included all enrolled participants who received at least one dose of bemcentinib in Part A.
If 1 participant in a cohort experienced a dose limiting toxicity (DLT) during Cycle 1, the cohort was expanded to 6 participants. If 2 of 3 or 2 of 6 participants in a cohort experience DLT no further dose escalation took place and the dose below was nominated as the MTD. DLT was assessed during the first 3 weeks of treatment (Cycle 1) with bemcentinib. DLT was defined as according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) \[NCI CTCAE\] version 4, considered unrelated to leukemia progression or intercurrent illness.
Outcome measures
| Measure |
Part A: Bemcentinib
n=36 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Maximum Tolerated Dose (MTD) of Bemcentinib (BGB324)
Loading dose for 3 days
|
600 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Part A: Maximum Tolerated Dose (MTD) of Bemcentinib (BGB324)
Maintenance dose
|
200 mg
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 28 days after last dose (up to 1452 days; maximum treatment exposure duration 1424 days)Population: The safety analysis population in Part B included all enrolled participants who received at least one dose of bemcentinib in Part B.
An AE was any untoward medical occurrence in a participant or clinical study participant administered a pharmaceutical product and which did not necessarily had a causal relationship with the product. A TEAE was defined as an AE that started or worsened after the first dose of the study intervention until 28 days after the last dose.
Outcome measures
| Measure |
Part A: Bemcentinib
n=14 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=16 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=18 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=18 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=20 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
14 Participants
|
16 Participants
|
18 Participants
|
18 Participants
|
20 Participants
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Baseline to end of the study (Part B: Maximum exposure duration was 1424 days)Population: The safety analysis population in Part B included all enrolled participants who received at least one dose of bemcentinib in Part B.
Number of participants with notable trends in physical examinations (including weight), vital signs (blood pressure \[BP\], heart rate \[HR\]), clinical laboratory test (including clinical chemistry, hematology and urinalysis), and ECG values over the time were reported in this outcome measure. Notable trends were defined as observations which were outside the normal range for these mentioned parameters as specified by the sponsor.
Outcome measures
| Measure |
Part A: Bemcentinib
n=14 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=16 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=18 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=18 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=20 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Number of Participants With Notable Trends in Physical Examination, Vital Signs, Clinical Laboratory Test and Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 28 days after last dose (up to 745 days, maximum exposure duration 717 days)Population: The safety analysis population in Part A included all enrolled participants who received at least one dose of bemcentinib in Part A.
An AE was any untoward medical occurrence in a participant or clinical study participant administered a pharmaceutical product and which did not necessarily had a causal relationship with the product. A TEAE was defined as an AE that started or worsened after the first dose of the study intervention until 28 days after the last dose.
Outcome measures
| Measure |
Part A: Bemcentinib
n=6 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=5 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=4 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=7 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
|
5 Participants
|
14 Participants
|
5 Participants
|
4 Participants
|
7 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to end of the study (Part A: Maximum exposure duration was 717 days)Population: The safety analysis population in Part A included all enrolled participants who received at least one dose of bemcentinib in Part A.
Number of participants with notable trends in physical examinations (including weight), vital signs (blood pressure \[BP\], heart rate \[HR\]), clinical laboratory test (including clinical chemistry, hematology and urinalysis), and ECG values over the time were reported as per investigator observation. Notable trends meant observations that were outside normal range as specified by sponsor.
Outcome measures
| Measure |
Part A: Bemcentinib
n=6 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=5 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=4 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=7 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A: Number of Participants With Notable Trends in Physical Examination, Vital Signs, Clinical Laboratory Test and Electrocardiogram (ECG) Values
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to end of the study (for Part A: maximum exposure duration 717 days, and for Part B: maximum exposure duration 1424 days)Population: Efficacy population included all participants from safety analysis population that met key eligibility criteria, have assessable disease at baseline and had at least 1 post-baseline response assessment; had received \>1 dose of bemcentinib (and combination agent in Part B2, B3 and B5).
AML: complete remission (CR): Bone marrow (BM) \<5% \& no myeloblasts with Auer rods; absolute neutrophil count(ANC) \>=1.0\*10\^9/L or \>=1000/μL; platelet count (PC) \>=100\*10\^9/L or \>=100000/μL:CR with incomplete hematologic recovery(CRi): BM \<5% and no myeloblasts with Auer rods; ANC \<1.0\*10\^9/L or \<1000/μL; PC \<100\*10\^9/L or \<100000/μL, CR with partial hematologic recovery (CRh): CR but ANC \> 0.5 × 10\^9/L and PC \> 50 × 10\^9/L; partial remission (PR): all CR hematologic criteria but decrease of myeloblasts to 5% to 25% and of pretreatment myeloblasts % by \>= 50%; MDS: CR: BM \<=5% myeloblasts, normal maturation of all cell lines, no evidence for dysplasia, Hb \>=11 g/dL;PC \>=100\*10\^9/L or 100000/μL; ANC \>=1.5\*10\^9/L or 1500/μL; PB 0%; marrow CR: \<=5% myeloblasts \& decrease by \>=50% over pretreatment value; CRh =CR with ANC \> 0.5\*10\^9/L and PC \> 50\*10\^9/L; PR: decrease of myeloblasts to 5% to 25% \& decrease of pretreatment myeloblast by \>= 50%; all hematologic criteria of CR.
Outcome measures
| Measure |
Part A: Bemcentinib
n=3 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=10 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=4 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=4 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=6 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
n=11 Participants
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=13 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
n=16 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=18 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A and B: Percentage of Participants With Objective Response (OR) as Per International Working Group Response Criteria
|
33.3 Percentage of participants
|
20.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
33.3 Percentage of participants
|
18.2 Percentage of participants
|
35.7 Percentage of participants
|
0 Percentage of participants
|
18.8 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to end of the study (for Part A: maximum exposure duration 717 days, and for Part B: maximum exposure duration 1424 days)Population: Efficacy population analyzed.
AML: SD= unchanged disease for at least 3 treatment cycles; MDS: SD = failure to achieve at least PR but no evidence of PD for at least 3 treatment cycles. AML: Absence of CR, Cri or PR and criteria for PD not met. MDS: PR = all CR criteria met if abnormal before treatment except for, myeloblasts decrease by 50% or more over pretreatment value but still \>5%, or less advanced French-American-British (FAB) or International Prognostic Scoring System (IPPS) category compared to pretreatment value; hematologic improvement; absolute values must last at least 6 weeks. MDS: PD = for participants with \<5% myeloblasts: a 50% or more increase in myeloblasts to more than 5% myeloblasts, for participants with 5% to 10% myeloblasts: a 50% or more increase to more than 10% myeloblasts, for participants with 10% to 20% myeloblasts: a 50% or more increase to more than 20% myeloblasts, for participants with 20% to 30% myeloblasts: a 50% or more increase to more than 30% myeloblasts.
Outcome measures
| Measure |
Part A: Bemcentinib
n=3 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=10 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=4 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=4 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=6 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
n=11 Participants
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=13 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
n=16 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=18 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A and B: Percentage of Participants With Stable Disease (SD) as Per International Working Group Response Criteria
|
0 Percentage of participants
|
0 Percentage of participants
|
25.0 Percentage of participants
|
25.0 Percentage of participants
|
0 Percentage of participants
|
27.3 Percentage of participants
|
14.3 Percentage of participants
|
30.8 Percentage of participants
|
37.5 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to end of the study (for Part A: maximum exposure duration 717 days, and for Part B: maximum exposure duration 1424 days)Population: Efficacy population analyzed.
AML and MDS: DCR= percentage of participants with OR and SD. AML: OR= CR, CRi, CRp, CRh and PR. MDS: OR= CR, PR, MR, PMR. AML: SD = unchanged disease for at least 3 treatment cycles; MDS: SD = failure to achieve at least PR but not evidence of PD for at least 3 treatment cycles.
Outcome measures
| Measure |
Part A: Bemcentinib
n=3 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=10 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=4 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=4 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=6 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
n=11 Participants
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=13 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
n=16 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=18 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A and B: Disease Control Rate (DCR) as Per International Working Group Response Criteria
|
33.3 Percentage of participants
|
20.0 Percentage of participants
|
25.0 Percentage of participants
|
25.0 Percentage of participants
|
33.3 Percentage of participants
|
45.5 Percentage of participants
|
50.0 Percentage of participants
|
30.8 Percentage of participants
|
56.3 Percentage of participants
|
16.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to end of the study (Part B: maximum exposure duration 1424 days)Population: Efficacy population analyzed. "Overall Number of Participants Analyzed": Participants evaluable for this outcome measure.
RFS: defined as the months from the date of response until the date of relapse as confirmed by blast counts assessment (date of the disease progression was used since disease progression is based in blast count assessment).
Outcome measures
| Measure |
Part A: Bemcentinib
n=2 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=5 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=3 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=3 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Relapse Free Survival (RFS)
|
6.61 Months
Interval 2.2 to 11.0
|
17.25 Months
Interval 2.3 to 44.7
|
—
|
3.08 Months
Interval 2.1 to 6.5
|
3.05 Months
Interval 2.6 to 12.9
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to end of the study (Part B: maximum exposure duration 1424 days)Population: Efficacy population analyzed.
Event was defined as death or progression. Duration of EFS was calculated as (days)= Date of onset of Event, subject death or censoring - Date of first intake of study treatment (Bemcentinib ) + 1. EFS data reported below is in months.
Outcome measures
| Measure |
Part A: Bemcentinib
n=11 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=13 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=16 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=18 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Event Free Survival (EFS)
|
2.69 Months
Interval 0.7 to 18.7
|
3.75 Months
Interval 0.7 to 46.7
|
4.13 Months
Interval 1.4 to 12.5
|
4.18 Months
Interval 0.7 to 28.1
|
2.33 Months
Interval 0.7 to 21.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1 of dosing up to end of the study (Part B: maximum exposure duration 1424 days)Population: Efficacy population analyzed.
OS was defined as the months from the first day of treatment until date of death for any cause. Participants who were alive at the time of the final analysis were censored at the date the participants were known to be alive.
Outcome measures
| Measure |
Part A: Bemcentinib
n=11 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=14 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=13 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=16 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=18 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part B: Overall Survival (OS)
|
18.0 Months
Interval 2.7 to 20.5
|
11.1 Months
Interval 3.9 to 24.7
|
6.4 Months
Interval 3.3 to 11.6
|
9.2 Months
Interval 4.6 to 34.0
|
8.0 Months
Interval 2.5 to 21.3
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Predose, 2, 4, 6 hours post dose on Day 1;predose and 6hours post dose on Day2, predose, 2,4,6,8 hours post dose on Day 3 and predose on Day 4 of Cycle 1; Predose collected on Day1 of each cycle up to and including Cycle 15 and at end of the study (EOS)Population: PK analysis population=participants who had 1 dose of bemcentinib \& evaluable PK data available. Part A arms combined based on maintenance dose. Part B was not combined as combinations were different or were for different indications; time to attaining steady state affected by magnitude of loading dose, exposure at steady state would only be determined by level of daily maintenance dose. As pre-specified in analysis plan, data for arms that received same maintenance dose were reported combined.
Predicted AUCss = area under the curve PK -time profile during 24 hours at steady state.
Outcome measures
| Measure |
Part A: Bemcentinib
n=10 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=21 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=5 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=14 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=15 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
n=17 Participants
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=17 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=20 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A and Part B: Pharmacokinetics (PK) Parameter: Area Under The Curve (0-tau) at Steady State (AUCss) for Bemcentinib
|
3310 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 2630
|
3810 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 2860
|
9390 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 4720
|
4910 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 2560
|
4650 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 3260
|
5320 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 2380
|
3510 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 2010
|
5090 nanogram*hour per milliliter (ng*h/mL)
Standard Deviation 2910
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 2, 4, 6 on Day 1; predose and 6 hours post dose on Day 2; predose, 2, 4, 6 and 8 hours post dose on Day 3 and predose on Day 4 of Cycle 1; Predose collected on Day 1 of each cycle up to and including Cycle 15 and at EOSPopulation: PK analysis population=participants who had 1 dose of bemcentinib \& evaluable PK data available. Part A arms combined based on maintenance dose. Part B was not combined as combinations were different or were for different indications; time to attaining steady state affected by magnitude of loading dose, exposure at steady state would only be determined by level of daily maintenance dose. As pre-specified in analysis plan, data for arms that received same maintenance dose were reported combined.
Observed maximum predicted PK concentration (Cmax) during 24 hours at steady state (Cmax, ss).
Outcome measures
| Measure |
Part A: Bemcentinib
n=10 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=21 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=5 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=14 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=15 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
n=17 Participants
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=17 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=20 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A and B: Pharmacokinetics Parameter: Maximum Observed Plasma Concentration (Cmax) for Bemcentinib
|
140 nanogram per milliliter (ng/mL)
Standard Deviation 110
|
162 nanogram per milliliter (ng/mL)
Standard Deviation 121
|
398 nanogram per milliliter (ng/mL)
Standard Deviation 200
|
210 nanogram per milliliter (ng/mL)
Standard Deviation 108
|
198 nanogram per milliliter (ng/mL)
Standard Deviation 137
|
228 nanogram per milliliter (ng/mL)
Standard Deviation 101
|
150 nanogram per milliliter (ng/mL)
Standard Deviation 84.7
|
219 nanogram per milliliter (ng/mL)
Standard Deviation 123
|
—
|
—
|
SECONDARY outcome
Timeframe: Pre-dose 2, 4, 6 on Day 1; predose and 6 hours post dose on Day 2; predose, 2, 4, 6 and 8 hours post dose on Day 3 and predose on Day 4 of Cycle 1; Predose collected on Day 1 of each cycle up to and including Cycle 15 and at EOSPopulation: PK analysis population=participants who had 1 dose of bemcentinib \& evaluable PK data available. Part A arms combined based on maintenance dose. Part B was not combined as combinations were different or were for different indications; time to attaining steady state affected by magnitude of loading dose, exposure at steady state would only be determined by level of daily maintenance dose. As pre-specified in analysis plan, data for arms that received same maintenance dose were reported combined.
Median half-life (t1/2) at steady state.
Outcome measures
| Measure |
Part A: Bemcentinib
n=10 Participants
Participants who received bemcentinib in Part A of the study.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=21 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=5 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDS
n=14 Participants
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
n=15 Participants
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
Part B1: Bemcentinib 400/200 mg, AML
n=17 Participants
Participants with AML who are unsuitable for intensive chemotherapy, as a result of advanced age and/or existing co-morbidities and should have relapsed following at least one line of therapy or be refractory to such prior therapy received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure was of 602 days.
|
Part B2: Bemcentinib 400/200 mg + Cytarabine, AML
n=17 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 1424 days. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
Part B3: Bemcentinib 400/200 mg + Decitabine, AML
n=20 Participants
Participants with AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 393 days. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
Part B4: Bemcentinib 400/200 mg, MDs
Participants with previously treated MDS (with the exception of deletion 5q MDS) including intermediate (int-2) or high-risk MDS and who received prior treatment for the same. Prior treatment included participants who received hypomethylating agents, decitabine or other approved treatments for MDS. Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 449 days.
|
Part B5: Bemcentinib 400/200 mg + Cytarabine, AML
Participants with relapsed or refractory AML who are unsuitable for intensive chemotherapy, due to advanced age and/or existing co-morbidities who must have received at least one prior treatment for AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Each cycle was of 21 days. Maximum exposure to treatment was of 462 days. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Part A and B: Pharmacokinetics Parameter: t1/2 for Bemcentinib
|
159 hours
Interval 67.5 to 608.0
|
124 hours
Interval 31.4 to 405.0
|
156 hours
Interval 87.3 to 384.0
|
157 hours
Interval 45.2 to 455.0
|
126 hours
Interval 58.2 to 362.0
|
155 hours
Interval 68.8 to 516.0
|
116 hours
Interval 43.6 to 507.0
|
112 hours
Interval 49.8 to 237.0
|
—
|
—
|
Adverse Events
Part A: BGB324 400/100 mg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 4 deaths
Part A: BGB324 600/200 mg
Serious events: 11 serious events
Other events: 14 other events
Deaths: 5 deaths
Part A: BGB324 900/300 mg
Serious events: 4 serious events
Other events: 5 other events
Deaths: 1 deaths
Part A: BGB324 200/100 mg
Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths
Part A: BGB324 400/200 mg
Serious events: 7 serious events
Other events: 7 other events
Deaths: 6 deaths
B1: BGB324 400/200 mg
Serious events: 8 serious events
Other events: 14 other events
Deaths: 10 deaths
B2: BGB324 400/200 mg + Cytarabine
Serious events: 12 serious events
Other events: 16 other events
Deaths: 12 deaths
B3: BGB324 400/200 mg + Decitabine
Serious events: 14 serious events
Other events: 17 other events
Deaths: 12 deaths
B4: BGB324 400/200 mg
Serious events: 13 serious events
Other events: 18 other events
Deaths: 13 deaths
B5: BGB324 400/200 mg + Cytarabine
Serious events: 16 serious events
Other events: 20 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Part A: BGB324 400/100 mg
n=6 participants at risk
Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 100 mg thereafter.
|
Part A: BGB324 600/200 mg
n=14 participants at risk
Participants received daily loading dose of bemcentinib 600 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter.
|
Part A: BGB324 900/300 mg
n=5 participants at risk
Participants received daily loading dose of bemcentinib 900 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 300 mg thereafter.
|
Part A: BGB324 200/100 mg
n=4 participants at risk
Participants received daily loading dose of bemcentinib 200 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 100 mg thereafter.
|
Part A: BGB324 400/200 mg
n=7 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter.
|
B1: BGB324 400/200 mg
n=14 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m\^2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
B2: BGB324 400/200 mg + Cytarabine
n=16 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m\^2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
B3: BGB324 400/200 mg + Decitabine
n=18 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
B4: BGB324 400/200 mg
n=18 participants at risk
Participants with intermediate (int-2) or high risk MDS received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter.
|
B5: BGB324 400/200 mg + Cytarabine
n=20 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Bacterial infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pneumonia
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
3/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Neutropenic sepsis
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Viral infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Wound abscess
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Uncoded
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pulmonary mycosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Salmonellosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Urinary tract infection enterococcal
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
57.1%
4/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
4/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
31.2%
5/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
33.3%
6/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
5/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gastrointestinal angiodysplasia haemorrhagic
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Oral bacterial infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Pyrexia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Multi-organ failure
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Fatigue
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Cardiac failure
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Acute myocardial infarction
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Myocardial infarction
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Pericardial haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Angina pectoris
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Enthesopathy
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Osteitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary granuloma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Glomerulonephritis acute
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood culture positive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
Other adverse events
| Measure |
Part A: BGB324 400/100 mg
n=6 participants at risk
Participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 100 mg thereafter.
|
Part A: BGB324 600/200 mg
n=14 participants at risk
Participants received daily loading dose of bemcentinib 600 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter.
|
Part A: BGB324 900/300 mg
n=5 participants at risk
Participants received daily loading dose of bemcentinib 900 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 300 mg thereafter.
|
Part A: BGB324 200/100 mg
n=4 participants at risk
Participants received daily loading dose of bemcentinib 200 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 100 mg thereafter.
|
Part A: BGB324 400/200 mg
n=7 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter.
|
B1: BGB324 400/200 mg
n=14 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m\^2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
B2: BGB324 400/200 mg + Cytarabine
n=16 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received cytarabine subcutaneously according to standard practice (20 mg/m\^2 twice daily for 10 days followed by a rest period of \<1 month according to persisting myelosuppression).
|
B3: BGB324 400/200 mg + Decitabine
n=18 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received decitabine (up to a maximum dose of 20 mg/m2 body surface area by intravenous infusion over one hour, repeated daily for five consecutive days \[i.e., a total of five doses per treatment cycle\]).
|
B4: BGB324 400/200 mg
n=18 participants at risk
Participants with intermediate (int-2) or high risk MDS received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter.
|
B5: BGB324 400/200 mg + Cytarabine
n=20 participants at risk
Participants with AML, received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 (21 days) followed by a maximum daily maintenance dose of 200 mg thereafter. In combination to this, participants received low dose cytarabine subcutaneously according to standard practice (dose of 20 mg subcutaneously twice daily for 10 days every 28 days).
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
6/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
40.0%
2/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
50.0%
2/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
85.7%
6/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
6/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
37.5%
6/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
38.9%
7/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
33.3%
6/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
55.0%
11/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
3/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
4/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
55.0%
11/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
4/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
60.0%
3/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
30.0%
6/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Stomatitis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
4/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
27.8%
5/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
5/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Dysphagia
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Faecal incontinence
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Colitis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gastrointestinal ulcer
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gingival hyperplasia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
31.2%
5/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Tongue discolouration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Anal ulcer
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Breath odour
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Mucous stools
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Oral herpes
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Pelvic pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Tongue coated
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Tooth development disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
40.0%
2/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
71.4%
5/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Pyrexia
|
50.0%
3/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
50.0%
7/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
30.0%
6/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Oedema peripheral
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
50.0%
2/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
30.0%
6/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
General physical health deterioration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Catheter site pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Chills
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Night sweats
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Oedema
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Tenderness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Terminal state
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Local swelling
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Asthenia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Malaise
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Catheter site haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Decreased activity
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Feeling hot
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Generalised oedema
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Electrocardiogram QT prolonged
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
60.0%
3/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
50.0%
2/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
6/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
37.5%
6/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
55.6%
10/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
27.8%
5/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
50.0%
10/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
3/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Weight decreased
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Platelet count decreased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
35.0%
7/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
White blood cell count increased
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Actinomyces test positive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood chloride increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Troponin I increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Weight increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Transaminases increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Urine leukocyte esterase positive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood creatine increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood glucose increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Crystal urine
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Electrocardiogram ST segment depression
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Fungal test positive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Nitrite urine present
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Protein urine present
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Investigations
Scan myocardial perfusion abnormal
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
50.0%
2/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
3/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
31.2%
5/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
5/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
43.8%
7/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
45.0%
9/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Leukopenia
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Haemorrhagic disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Lymph node calcification
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
6/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
50.0%
2/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
30.0%
6/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
35.7%
5/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
5/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Iron overload
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Oedema peripheral
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
4/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
16.7%
3/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
5/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
4/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
3/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
4/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary congestion
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Nasopharyngitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary arterial hypertension
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Sinusitis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Device related infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Infection
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Laryngitis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Localised infection
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Oropharyngeal candidiasis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Parotitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Sepsis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Skin infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Arthritis infective
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Cystitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Folliculitis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Wound infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
4/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
22.2%
4/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Blepharitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Transfusion reaction
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Allergic transfusion reaction
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Haemarthrosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
42.9%
3/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Dizziness
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
28.6%
2/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Dysgeusia
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Orthostatic intolerance
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Tremor
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Syncope
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Movement disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Nuchal rigidity
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Parkinson's disease
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Nervous system disorders
Polyneuropathy
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Madarosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Hypersensitivity vasculitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Skin wound
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
18.8%
3/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Bone lesion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Growing pains
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Haemarthrosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Hypertonia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Hypotension
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Haematoma
|
33.3%
2/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
5/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Epistaxis
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Phlebitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Hypertension
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Skin ulcer
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Intra-abdominal haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Rectal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Tongue haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Vascular disorders
Venous haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Atrial fibrillation
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Angina pectoris
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Dyspnoea
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Oedema peripheral
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Atrioventricular block
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Tachyarrhythmia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
21.4%
3/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Erectile dysfunction
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Food aversion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Conjunctival haemorrhage
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Dry eye
|
16.7%
1/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Vision blurred
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
25.0%
1/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Amaurosis fugax
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Blindness
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Cataract
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Intraocular haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Retinal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Retinopathy
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Scleral haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Uveitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Eye disorders
Visual impairment
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
1/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
10.0%
2/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
2/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Urethral haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Reproductive system and breast disorders
Genital pain
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Reproductive system and breast disorders
Oedema genital
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Reproductive system and breast disorders
Penile oedema
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Reproductive system and breast disorders
Penile haemorrhage
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Reproductive system and breast disorders
Vulval abscess
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
14.3%
1/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Hepatic congestion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
12.5%
2/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Anuria
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Chromaturia
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Nephropathy toxic
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Urge incontinence
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Impaired healing
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
7.1%
1/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Injection site haematoma
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Injection site phlebitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Injection site reaction
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
6.2%
1/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
General disorders
Thrombosis in device
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
11.1%
2/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
20.0%
4/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Lung infection
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
15.0%
3/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.6%
1/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/6 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/5 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/4 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/7 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/14 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/16 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
0.00%
0/18 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
5.0%
1/20 • Up to 28 days after last dose (for Part A: up to 745 days, maximum exposure duration 717 days, and for Part B: up to 1452 days, maximum exposure duration1424 days)
Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred. SAS analyzed by dose group or combination in Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place